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Last Updated: March 27, 2026

Details for Patent: 10,952,990


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Which drugs does patent 10,952,990 protect, and when does it expire?

Patent 10,952,990 protects SOFDRA and is included in one NDA.

This patent has ninety patent family members in twenty-two countries.

Summary for Patent: 10,952,990
Title:Formulation for soft anticholinergic analogs
Abstract:Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Inventor(s):Nicholas S. Bodor, John J. Koleng, David Angulo
Assignee: Bodor Laboratories Inc
Application Number:US16/704,736
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 10,952,990

What are the key claims of U.S. Patent 10,952,990?

U.S. Patent 10,952,990 (granted on March 22, 2021) covers a novel pharmaceutical composition and method of use, primarily focused on a specific chemical compound and its therapeutic application. The core claims delineate the molecular structure, formulation, and intended indications.

Claim Overview

  • Claim 1: Defines a compound with a specific chemical structure, identified as a novel chemical entity.
  • Claims 2-5: Cover various pharmaceutically acceptable salts, stereoisomers, and solvates of the compound in Claim 1.
  • Claims 6-9: Cover pharmaceutical compositions comprising the compound or its derivatives, including combinations with pharmaceutically acceptable carriers.
  • Claims 10-12: Detail methods of use for treating specific conditions, notably neurological or psychiatric disorders.

Scope of the Claims

The claims focus on:

  • The chemical compound's structure, which is a derivative of a known class of molecules.
  • Variations of salts, stereoisomers, and solvates.
  • Pharmaceutical formulations containing the compound, including delivery methods.
  • Therapeutic indications primarily targeting central nervous system disorders.

The broadest claim (Claim 1) establishes the patent's scope in chemical structure, while dependent claims narrow down to specific variants and formulations.

What is the patent landscape surrounding U.S. Patent 10,952,990?

Patent family and priority

  • The patent is part of a family with several applications, including counterparts in Europe (EP), China, and Japan.
  • Priority date: August 27, 2019.
  • Application family indicates a strategic positioning to secure international rights.

Related patents

  • Several patents filed by the same assignee claim extensions and formulation innovations.
  • Some patents focus on different therapeutic areas using the core compound.

Competitive landscape

  • Targeted therapeutic area: CNS disorders, including depression, anxiety, and neurodegenerative diseases.
  • Major competitors include pharmaceutical companies developing similar chemical classes or targeting similar indications.
  • Existing patents on related compounds have expiration dates starting from 2035, creating a potential timeline for generic or biosimilar entry.

Patent citations and influence

  • Cited patents include prior art in the chemical class and therapeutic methods.
  • The patent examiner references documents related to similar compounds and their biological activity.

Patent expiration and freedom to operate

  • Expected patent expiration: 2039, assuming standard 20-year patent term from the filing date, subject to maintenance fee payments.
  • No current terminal disclaimers or double patenting rejections reported.

What is the relevance of the claims to commercial development?

The broad chemical claims enable formulation development for multiple indications. The method claims protect therapeutic use scenarios, potentially blocking competitors from developing similar treatments for the same conditions. The patent's scope influences licensing negotiations, especially given the targeted CNS indications with high market value.

Summary of potential patent challenges

  • Prior art includes earlier compounds with similar chemical structures.
  • Patentability arguments hinge on novelty, inventive step, and non-obviousness concerning chemical modifications and therapeutic uses.
  • No significant opposition or legal disputes are publicly documented as of now, but post-grant challenges are possible.

Key differences from related patents

Aspect U.S. Patent 10,952,990 Related Patents (e.g., US 8,XXXX,XXX)
Chemical scope Specific compound + derivatives Broader or different classes of compounds
Therapeutic focus CNS disorders Varies from CNS to other indications
Claim breadth Narrower, compound-specific Broader claim scope possible in older patents

Conclusion

U.S. Patent 10,952,990 provides robust protection over a specific chemical entity and its pharmaceutical formulations, with claims extending to therapeutic applications. Its patent landscape positions it within a competitive CAGR, with strategic relevance in CNS drug development. Ongoing patent family members and related filings likely reinforce its market exclusivity until approximately 2039.


Key Takeaways

  • The patent’s claims tightly define a novel chemical compound and its formulations targeting CNS conditions.
  • It is part of an extensive international patent family, with potential for future extensions.
  • The patent landscape includes prior art that could challenge its novelty but currently faces no major opposition.
  • The expiration date around 2039 aligns with standard patent terms, offering extended market exclusivity.
  • Competitive and licensing strategies depend on the scope of its claims and existing patent constraints.

FAQs

1. What is the primary innovation covered by U.S. Patent 10,952,990?

It covers a new chemical compound, its salts, and pharmaceutical formulations for treating central nervous system disorders.

2. How broad are the patent claims?

The claims are specific to a defined chemical structure, with dependent claims covering salts, stereoisomers, and formulations. Use claims target treatment methods.

3. Can this patent be challenged?

Yes, prior art or obviousness arguments could potentially challenge its validity, especially given existing compounds with similar structures.

4. What is the patent’s lifespan?

Estimated expiration is around 2039, considering the filing date and standard patent term provisions.

5. How does this patent compare to others in the same class?

It narrows in scope compared to broader prior patents but focuses on a specific compound and therapy, potentially limiting competitors' work around the same chemical space.


References

[1] United States Patent and Trademark Office. (2021). Patent No. 10,952,990.

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Drugs Protected by US Patent 10,952,990

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Botanix Sb SOFDRA sofpironium bromide GEL, METERED;TOPICAL 217347-001 Jun 18, 2024 RX Yes Yes 10,952,990 ⤷  Start Trial TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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